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Comparison of Pantoprazole and Ranitidine in Dyspepsia

This study is currently recruiting participants.
Verified November 2012 by Akdeniz University
Sponsor:
Information provided by (Responsible Party):
Akdeniz University
ClinicalTrials.gov Identifier:
NCT01737840
First received: November 24, 2012
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

The H0 hypothesis of the study there is no difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency deparment.

The H1 hypothesis is there is difference between pantoprazole and ranitidine in treating patients presented with dyspepsia to the emergency department.


Condition Intervention Phase
Dyspepsia
 Drug: Pantoprazole
Drug: Ranitidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravenous Pantoprazole vs Ranitidine in Dyspepsia in Emergency Department: A Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

Further study details as provided by Akdeniz University:

Primary Outcome Measures:
  • Visual analogue scale score [ Time Frame: 30th and 60th minutes ] [ Designated as safety issue: No ]
    The investigators are measuring the change of pain from the baseline to the 30th and 60th minutes by visual anologue scale.


Secondary Outcome Measures:
  • Need for additional drug [ Time Frame: 60 th minute ] [ Designated as safety issue: No ]
    The investigators are measuring the need for additional drug at the end of 60 minutes.


Estimated Enrollment: 70
Study Start Date: October 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: pantoprazole
Intravenous pantoprazole 40 mg flacon
 Drug: Pantoprazole
Other Name: Pantpas
Active Comparator: ranitidine
Intravenous ranitidine 50 mg
 Drug: Ranitidine
Other Name: Ulcuran

Detailed Description:

Dyspepsia is one of the common complaints in emergency department. Protone pomp inhibitors, H2 receptor blockers and anti-acids are common drugs for treating dyspepsia in emergency department. However there is no study in the emergency department comparing the effectiveness of these drugs. So the investigators planned this study which drug is effective in these patients in order to provide a cost-effective treatment in dyspeptic patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Epigastric pain
  • Older than 18 years old

Exclusion Criteria:

  • Diagnosed as cholecystitis, pancreatitis, myocardial infarction, etc.. at the end of the emergency deparment evaluation period.
  • Pregnancy
  • Patients with unstable vital signs
  • Patients used anti-acid, H2 receptor blockers and proton pomp inhibitors in the last one hour.
  • Allergy to H2 receptor blockers and proton pomp inhibitors.
  • Patients denied to give inform consent and who are illiterate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01737840

Contacts
Contact: Cenker Eken, Proffesor 00905056251217 cenkereken@akdeniz.edu.tr

Locations
Turkey
Akdeniz University Recruiting
Antalya, Turkey, 07050
Contact: Cenker Eken, Proffesor     00905056251217     cenkereken@akdeniz.edu.tr    
Sub-Investigator: Engin Senay, Resident            
Sponsors and Collaborators
Akdeniz University
Investigators
Study Director: Cenker Eken, Proffesor Akdeniz University
  More Information

Additional Information:
The web adress of the organization which this study is conducted.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT01737840     History of Changes
Other Study ID Numbers: 160
Study First Received: November 24, 2012
Last Updated: November 29, 2012
Health Authority: Turkey: Ministry of Health

Keywords provided by Akdeniz University:
dyspepsia
pantoprazole
ranitidine
emergency department

Additional relevant MeSH terms:
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Ranitidine
Ranitidine bismuth citrate
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Proton Pump Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013